EUCTR2018-004212-21-GB进行中（未招募）1 期
A Phase 2b/3a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of AMAG-423, a Digoxin Immune Fab, in Antepartum Subjects with Severe Preeclampsia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Has a foetal gestational age of 23 0/7 to 31 6/7 weeks. Gestational age should be confirmed by best obstetrical estimate using one of the following three options:
- •Confirmed last menstrual period (LMP) and confirmatory ultrasound
- •Ultrasound alone when LMP is not known or reliable
- •Known date of conception in instances of assisted reproductive technology
- •2. At least 18 years of age or older
- •3. Will be treated with expectant management
- •4. Singleton gestation
- •5. Meets modified ACOG (2013) criteria for either preeclampsia or chronic hypertension with superimposed preeclampsia, as specified below:
- •Preeclampsia as defined by:
- •a. Blood pressure greater than or equal to 140 mmHg systolic or greater than or equal to 90 mmHg diastolic on two occasions at least 4 hours apart after 20 weeks of gestation in a woman with a previously normal blood pressure; OR
- •b. Blood pressure greater than or equal to 160 mmHg systolic or greater than or equal to 110 mmHg diastolic, hypertension can be confirmed within a short interval (minutes) to facilitate timely antihypertensive therapy;
- •I. Proteinuria:
- •1. Greater than or equal to 300 mg per 24-hour urine collection (or this amount extrapolated from a timed collection); OR
- •2. Protein/creatinine ratio greater than or equal to 0.3 (each measured as mg/dL)
- •3. Dipstick reading of 3+ (used only if more quantitative methods not available)
- •OR in the absence of proteinuria, hypertension with the new onset of any of the following:
- •ii. Thrombocytopenia – platelet count less than 100,000/microliter
- •iii. Renal insufficiency – serum creatinine concentrations greater than 1.1 mg/dL or a doubling of the serum creatinine concentration in the absence of other renal disease
- •iv. Impaired liver function as indicated by abnormally elevated blood concentrations of liver enzymes (two times upper limit of normal for local lab)
- •Chronic hypertension with superimposed preeclampsia as defined by:
- •a. A sudden increase in previously well controlled hypertension or escalation of antihypertensive medications; OR
- •b. New onset proteinuria or a sudden increase in proteinuria in a woman with known proteinuria before or early in pregnancy.
- •6. Meets modified ACOG (2013) criteria for either preeclampsia with severe features or chronic hypertension with superimposed preeclampsia with severe features, as specified below:
- •Preeclampsia with severe features as defined by at least one of the below:
- •a. Systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher on two occasions at least 4 hours apart (unless antihypertensive therapy is initiated before this time)
- •b. Thrombocytopenia – platelet count less than 100,000/microliter
- •c. Impaired liver function as indicated by abnormally elevated blood concentrations of liver enzymes (two times upper limit of normal for local lab)
- •d. Progressive renal insufficiency as defined by serum creatinine concentrations greater than 1.1 mg/dL or a doubling of the serum creatinine concentration in the absence of other renal disease
- •Chronic hypertension with superimposed preeclampsia with severe features as defined by at least one of the below:
- •a. Systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher despite escalation of antihypertensive therapy
- •b. Thrombocytopenia – platelet count less than 100,000/microliter
- •c. Impaired liver function as indicated by abnormally elevated blood concentrations of liver enzymes (two times upper
排除标准
- •1. Prior to randomisation, the decision to induce or deliver the subject within 24 hours has been made
- •2. Weight > 150 kg
- •3. Eclampsia
- •4. Significant antecedent obstetrical problems which may, in the opinion of the investigator, interfere with study assessments or safe participation in the study
- •5. Evidence of non-reassuring foetal well-being
- •6. Evidence of clinically significant foetal anomaly or known chromosomal abnormality
- •7. Chronic renal disease
- •8. Active hepatic disease, antiphospholipid antibody syndrome, or lupus
- •9. Medical or psychiatric disorder which is unstable or which might, in the opinion of the investigator, interfere with study assessments or safe participation in the study
- •10. Evidence on medical history/evaluation of use of or need for digitalis-like products currently or in the future (e.g., diagnosis of atrial fibrillation)
- •11. History of an anaphylactic allergic reaction to previous medication, atopy, or allergic reactions to pineapple enzyme bromelain, papain, chymopapain, or other papaya extracts. (Potential subjects with this history may be more susceptible to allergic reactions to DIF).
- •12. Prior use of antibodies/Fab fragments from sheep (e.g. Digibind®, DigiFab®, CroFab®)
- •13. Serum creatinine = 2.0 mg/dL
- •14. Platelet count < 50,000/µL
- •15. Pulmonary oedema requiring treatment with a diuretic
- •16. Estimated foetal weight < 5th percentile
- •17. Any investigational drug use within 30 days of screen
- •18. Planned interventional clinical study participation for infants
- •19. Current history of methamphetamine or cocaine abuse
研究者
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